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Diaphragmatic Breathing Exercise for Patients Undergoing Arthrodesis Surgery for Adolescent Idiopathic Scoliosis.

Primary Purpose

Adolescent Idiopathic Scoliosis, Spinal Fusion, Pain Management

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
STANDARD PHYSIOTHERAPY TREATMENT
EXPERIMENTAL diaphragmatic breathing exercise
Sponsored by
Antonio Culcasi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring spinal fusion, early rehabilitation, diaphragmatic breathing exercise, Adolescent Idiopathic Scoliosis

Eligibility Criteria

12 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All subjects hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis, aged from 12 and 24 years will be consecutively enrolled.

Exclusion Criteria:

  • Subjects who cannot understand the Italian language and who do not provide consent to study will be excluded.

Sites / Locations

  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

STANDARD PHYSIOTHERAPY TREATMENT - CTL GROUP

EXPERIMENTAL diaphragmatic breathing exercise - EXP GROUP

Arm Description

Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis.

Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis.

Outcomes

Primary Outcome Measures

intensity of pain
numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").

Secondary Outcome Measures

intensity of pain (short term)
numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").
TUG - Time Up and Go
Timed up and go is a simple test to measure a person's mobility level and requires static and dynamic balancing skills. It consists of measuring how many seconds it takes the patient to get up from the chair, walk a distance of 3 meters, turn around, return to the chair and sit down again.

Full Information

First Posted
March 26, 2022
Last Updated
February 28, 2023
Sponsor
Antonio Culcasi
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1. Study Identification

Unique Protocol Identification Number
NCT05311826
Brief Title
Diaphragmatic Breathing Exercise for Patients Undergoing Arthrodesis Surgery for Adolescent Idiopathic Scoliosis.
Official Title
Effectiveness of Postoperative Respiratory Physiotherapy for Pain Management in Patients Undergoing Spinal Fusion for Adolescent Idiopathic Scoliosis: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Antonio Culcasi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe intervention that can be introduced for pain management. The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative care in patients undergoing spinal fusion for adolescent idiopathic scoliosis.
Detailed Description
Adolescent idiopathic scoliosis (AIS) is a common orthopedic condition with a prevalence of 2-3% in children aged from 10 to 16 years. It is a developmental deformity that affects both physical and psychological domains, interfering with self-esteem and mental well-being. Diagnosis is made within the first 18 years of life; in some cases, instrumented arthrodesis surgery is required, performed within the age of 25. Corrective surgery for scoliosis can be a stressful intervention for patients and their caregivers. Postoperative pain is the major concern for patients undergoing orthopedic surgery. Significant postoperative pain also adversely affects other outcomes by hindering the healing process and delaying rehabilitation with loss of movement and walking. After arthrodesis the pain reported by the patients is significant. Various strategies have been explored for acute pain management in patients undergoing surgery for scoliosis, with a focus on the first days post surgery. The link between breathing, lumbar spine function and pain perception is an aspect that has always been studied. The diaphragm plays an important role in spinal control and in the management of pain perception. Dysfunction of the diaphragm can lead to alterations in the biomechanics of the lumbar spine, with less proprioceptive abilities, less spinal mobility and reduced the spinal column's functionality of the tissues. Diaphragmatic rehabilitation techniques produce significant and clinically relevant improvements in the treatment of pathologies of the spine and especially in the management of painful symptoms. A systematic review highlights how pain is able to influence the flow, frequency and volume of the respiratory act. At the same time, a regulation of breathing can be an useful tool in the control of painful symptoms. After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe tool that can be introduced for the control of painful symptoms. The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative phase in patients undergoing arthrodesis surgery for adolescent idiopathic scoliosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Spinal Fusion, Pain Management, Exercise
Keywords
spinal fusion, early rehabilitation, diaphragmatic breathing exercise, Adolescent Idiopathic Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
it will be masking also data analyzer
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STANDARD PHYSIOTHERAPY TREATMENT - CTL GROUP
Arm Type
Active Comparator
Arm Description
Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis.
Arm Title
EXPERIMENTAL diaphragmatic breathing exercise - EXP GROUP
Arm Type
Experimental
Arm Description
Patients aged from 12 to 24 years hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis.
Intervention Type
Procedure
Intervention Name(s)
STANDARD PHYSIOTHERAPY TREATMENT
Intervention Description
The standard postoperative rehabilitation process starts from the first postoperative day. Two sessions are provided daily, with the exception of Sunday and Saturday afternoon. A single physiotherapy session, lasting 30 minutes, can include bed exercises for upper and lower limbs and recovery of autonomy (sitting position, standing and ambulation). In this phase, the sessions are characterized by educational and counseling activities. The patient will be encouraged to carry out the activities independently.
Intervention Type
Procedure
Intervention Name(s)
EXPERIMENTAL diaphragmatic breathing exercise
Intervention Description
The subjects in the intervention group (EXP) will receive, in addition to standard physiotherapy treatment, diaphragmatic breathing exercise. Four exercises in different position (supine and side lying) will be provided for each physiotherapy session by a senior physiotherapist. Patients will be instructed to perform the same exercises independently to achieve relaxation and relief of pain symptoms.
Primary Outcome Measure Information:
Title
intensity of pain
Description
numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").
Time Frame
The pain will be detected 3 times a day (8am/2 pm/8 pm) starting from the day of the first rehabilitation treatment until the fifth postoperative day.
Secondary Outcome Measure Information:
Title
intensity of pain (short term)
Description
numeric rating scale (NRS) (from 0 to 10); The 11-point numerical scale ranges from "0" representing one pain extreme (eg "No pain") to "10" representing the other pain extreme (eg "More severe pain than you can imagine" or "worst pain imaginable").
Time Frame
the values of the NRS scale will be detected before and after the rehabilitation treatment up to fifth day
Title
TUG - Time Up and Go
Description
Timed up and go is a simple test to measure a person's mobility level and requires static and dynamic balancing skills. It consists of measuring how many seconds it takes the patient to get up from the chair, walk a distance of 3 meters, turn around, return to the chair and sit down again.
Time Frame
the TUG test will be administered during the 5th postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects hospitalized for corrective arthrodesis surgery with Adolescent Idiopathic Scoliosis (AIS) diagnosis, aged from 12 and 24 years will be consecutively enrolled. Exclusion Criteria: Subjects who cannot understand the Italian language and who do not provide consent to study will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
antonio culcasi, PT
Phone
00390516366354
Email
antonio.culcasi@ior.it
First Name & Middle Initial & Last Name or Official Title & Degree
mattia morri, PT
Phone
00390516366354
Email
mattia.morri@ior.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
antonio culcasi, PT
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
State/Province
Emilia Romagna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
antonio culcasi, PT
Phone
00390516366354
Email
antonio.culcasi@ior.it
First Name & Middle Initial & Last Name & Degree
mattia morri, PT
Phone
00390516366354
Email
mattia.morri@ior.it

12. IPD Sharing Statement

Plan to Share IPD
No
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Diaphragmatic Breathing Exercise for Patients Undergoing Arthrodesis Surgery for Adolescent Idiopathic Scoliosis.

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